CAINA

Basic Information

• Brand Name: CAINA
• Primary DI: 06971564465236
• Version / Model: 23G×1.5-02
• Catalog Number: CN2315
• Company Name: Jiangsu Caina Medical Co.,Ltd
• Labeler DUNS: 544543513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-05
• Public Version: 1
• Public Version Date: 2021-02-15
• Public Version Status: New
• Public Device Record Key: 6fca1b42-f219-424e-99cd-e5c6a31852a2

Device Description

Safety needle 23Gx1.5”.The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.The safety needle contained in a sterility maintenance package.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2
MEG	Syringe, Antistick	General Hospital	880.5860	2
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16971564465233	GS1		100	In Commercial Distribution
Primary	06971564465236	GS1
Package	26971564465230	GS1		8	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K193526	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	23	Gauge
Length	1.5	Inch